Saquinavir

WHY is this medicine prescribed?

Saquinavir is used in combination with ritonavir (Norvir) and other medications to treat human immunodeficiency virus (HIV) infection. Saquinavir is in a class of medications called protease inhibitors. It works by decreasing the amount of HIV in the blood. Although saquinavir does not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer. Taking these medications along with practicing safer sex and making other lifestyle changes may decrease the risk of transmitting the HIV virus to other people.

Are there OTHER USES for this medicine?

Saquinavir is sometimes used with ritonavir (Norvir) and other medications to help prevent infection in healthcare workers or other people who were exposed to HIV. Talk to your doctor about the risks of taking this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Saquinavir comes as a capsule and a tablet to take by mouth. It is usually taken at the same time as ritonavir (Norvir) two times a day within 2 hours after a full meal. It may be easier to remember to take saquinavir if you take it with meals. Take saquinavir at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take saquinavir exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not chew, or crush them.

If you are not able to swallow the capsule whole, you can take saquinavir by opening the capsule and mixing the contents with sugar syrup, sorbitol, or jam. To prepare each dose, add 3 teaspoons (15 mL) of sugar syrup, sorbitol, or jam to an empty container. Open the saquinavir capsule and add the contents to the container. Stir the mixture for 30 to 60 seconds. If you used cold syrup, sorbitol, or jam, wait for the mixture to come to room temperature before eating. Be sure to eat the entire mixture so that you receive the full dose.

Continue to take saquinavir even if you feel well. Do not stop taking saquinavir without talking to your doctor. If you miss doses, take less than the prescribed dose or stop taking saquinavir, your condition may become more difficult to treat.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with saquinavir and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

What SPECIAL PRECAUTIONS should I follow?

Before taking saquinavir,

• tell your doctor and pharmacist if you are allergic to saquinavir, any other medications, lactose, or any of the other ingredients in saquinavir capsules or tablets. Your doctor may tell you not to take saquinavir. Ask your pharmacist for a list of the ingredients.

• tell your doctor if you are taking any of the following medications: alfuzosin (Uroxatral); atazanavir (Reyataz, in Evotaz); clarithromycin (Biaxin, in Prevpac); clozapine (Clozaril, Fazaclo, Versacloz); dasatinib (Sprycel); ergot medications such as dihydroergotamine (D.H.E. 45, Migranal), ergoloid mesylates (Hydergine), ergonovine (Ergotrate), ergotamine (Ergomar, in Cafergot, in Migergot, others), and methylergonovine (Methergine); erythromycin (E.E.S., E-mycin, Erythrocin, others); halofantrine; haloperidol (Haldol); certain medications for irregular heartbeat such as amiodarone (Nexterone, Pacerone), disopyramide (Norpace), dofetilide (Tikosyn), flecainide (Tambocor), lidocaine (Xylocaine), propafenone (Rhythmol), and quinidine (in Nuedexta); lovastatin (Altoprev); lurasidone (Latuda); medications for mental illness and nausea such as chlorpromazine, and thioridazine; midazolam by mouth; pentamidine (Nebupent, Pentam); pimozide (Orap); quinine (Qualaquin); rifampin (Rifadin, Rimactane, in Rifamate, Rifater); sildenafil (only Revatio brand used for lung disease); simvastatin (Zocor, Flolopid, in Vytorin); sunatinib (Sutent); tacrolimus (Astagraf XL, Envarsus XR, Prograf ); trazodone; triazolam (Halcion); or ziprasidone (Geodon). Also tell your doctor or pharmacist if you are taking rilpivirine (Edurant, in Juluca, Odefsey, Complera) or if you have stopped taking it within the past two weeks. Your doctor will probably tell you not to take saquinavir if you are taking one or more of these medications.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking or plan to take. Be sure to mention any of the following: anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); antifungals such as itraconazole (Onmel, Sporanox) and ketoconazole benzodiazepines such as alprazolam (Xanax), clorazepate (Gen-Xene, Tranxene), diazepam (Diastat, Valium), and flurazepam; beta blockers such as atenolol (Tenormin, in Tenoretic), labetalol (Trandate), metoprolol (Lopressor, Toprol XL, in Dutoprol, in Loressor HCT), nadolol (Corgard, in Corzide), and propranolol (Hemangeol, Inderal, Innopran); bosentan (Tracleer); calcium channel blockers such as amlodipine (Norvasc, in Caduet, Lotrel, others), diltiazem (Cardizem, Cartia, Tiazac, others), felodipine, isradipine, nicardipine (Cardene), nifedipine (Adalat, Afeditab CR, Procardia), nimodipine (Nymalize), nisoldipine (Sular), and verapamil (Calan, Verelan, in Tarka); certain cholesterol-lowering medications (statins) such as atorvastatin (Lipitor, in Caduet); cobicistat (Tybost, in Evotaz, Genvoya, Prezcobix, and Stribild); corticosteroids such as betamethasone, budesonide (Entocort, Pulmicort, Uceris, in Symbicort), ciclesonide (Alvesco, Zetonna, Omnaris), dexamethasone, fluticasone (Arnuity Ellipta, Flonase, Flovent, in Advair, others), methylprednisone, mometasone (Asmanax, Dulera), prednisone (Rayos), and triamcinolone (Kenalog); colchicine (Colcrys, Mitigare); digoxin (Lanoxin); fentanyl (Abstral, Actiq, Duragesic, others); certain immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), and sirolimus (Rapamune); medications to treat HIV or AIDS including indinavir (Crixivan), lopinavir with ritonavir (Kaletra), maraviroc (Selzentry), nelfinavir (Viracept), or tipranavir with ritonavir (Aptivus); certain medications for irregular heartbeat such as ibutilide (Corvert), and sotalol (Betapace, Sorine, Sotylize); medications to treat seizures such as carbamazepine (Carbatrol, Epitol, Tegretol, others), phenytoin (Dilantin, Phenytek), and phenobarbital; methadone (Dolophine, Methadose); nefazodone; omeprazole (Prilosec, in Yosprela, Zegerid); certain phosphodiesterase (PDE5) inhibitors such as sildenafil (Viagra), tadalafil (Adcirca, Cialis), and vardenafil (Levitra, Staxyn); quetiapine (Seroquel); quinupristin and dalfopristin (Synercid); rifabutin (Mycobutin); salmeterol (Serevent, in Advair); and certain tricyclic antidepressants including amitriptyline, clomipramine (Anafranil), imipramine (Surmontil, Tofranil), and maprotiline. Other medications may interact with saquinavir, so be sure to tell your doctor and pharmacist about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor what herbal products you are taking or plan to take, especially St. John's wort, and garlic capsules.

• you should know that saquinavir may decrease the effectiveness of hormonal contraceptives (birth control pills, patches, rings, or injections). Talk to your doctor about using another form of birth control.

• tell your doctor if you drink or have ever drunk large amounts of alcohol, and if you or anyone in your family has or has ever had diabetes. Also tell your doctor if you have or have ever had an irregular heartbeat, high cholesterol or triglycerides (fats in the blood); hemophilia (a bleeding disorder); conditions in which the body is not able to produce enough lactase or cannot tolerate lactose, or heart or kidney disease.

• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking saquinavir, call your doctor. You should not breastfeed if you are infected with HIV or are taking saquinavir.

• you should be aware that your body fat may increase or move to different areas of your body, such as your upper back, neck (''buffalo hump''), breasts, and around your stomach. You may notice a loss of body fat from your face, legs, and arms.

• you should know that you may experience hyperglycemia (increases in your blood sugar) while you are taking this medication, even if you do not already have diabetes. Tell your doctor immediately if you have any of the following symptoms while you are taking saquinavir: extreme thirst, frequent urination, extreme hunger, blurred vision, or weakness. It is very important to call your doctor as soon as you have any of these symptoms, because high blood sugar that is not treated can cause a serious condition called ketoacidosis. Ketoacidosis may become life-threatening if it is not treated at an early stage. Symptoms of ketoacidosis include dry mouth, nausea and vomiting, shortness of breath, breath that smells fruity, and decreased consciousness.

• you should know that while you are taking medications to treat HIV infection, your immune system may get stronger and begin to fight other infections that were already in your body or cause other conditions to occur. This may cause you to develop symptoms of those infections or conditions. If you have new or worsening symptoms after starting treatment with saquinavir, be sure to tell your doctor.

What SPECIAL DIETARY instructions should I follow?

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Saquinavir may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• stomach pain
• nausea
• vomiting
• constipation
• tiredness
• back pain
• dry lips or skin
• fever

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• rash, itching, swelling of eyes, face, mouth, throat, or lips, difficulty breathing or swallowing
• blistering or peeling skin
• yellowing of the skin or eyes, loss of appetite, flu like symptoms, extreme tiredness, dark colored urine, light colored stools, pain in the upper right part of the stomach
• dizziness, lightheadedness, slow, irregular, or pounding heartbeat, fainting

Saquinavir may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• throat pain

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during your treatment to check your body's response to saquinavir. Your doctor may also order an electrocardiogram (ECG; test that measures the electrical activity in the heart) before and during your treatment.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.